Process Validation Engineer

Our Process Validation Engineer plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include providing hands on support in the development and execution of products, programs and processes designed to support QuVa Pharma product introduction and continued robustness as necessary to meet cGMP and DEA regulatory and company compliance requirements. This role will be the primary liaison between Quality Compliance, Analytical Chemistry, Operations, and logistics with direct responsibilities for process introduction, transfer, and improvement. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

What the Process Validation Engineer Does Each Day:

• Leads teams of personnel dedicated to research, design, and execution of new product formulation introduction and commercialized product improvement objectives

• Generates and executes development, validation, and engineering documentation necessary to formally capture product introductions, process investigations, and process improvements.

• Supports development of appropriate Beyond Use Dating based on product formulation capabilities

• Provides technical assessment of product formulations with respect to container closure and delivery systems

• Partners with Quality Compliance in the development and routine implementation of quality processes required to support technical related programs (i.e. Change Control, Investigations, Master Batch Records)

• Supports the development and execution of QuVa Pharma policies, procedures, standards, and guidelines related to company validation programs and technical areas (Production, Processes, New Formulation Introduction, etc.)

• Engages with Commercial Operations to ensure production processes are appropriately designed to ensure on- time supply of products to meet customer requirements

• Provides compounder and formulator training with respect to new products or processes and/or process improvements as necessary to fulfill planned knowledge transfer requirements

• Provides Quality Partners, Commercial Operations, and Executive Management visibility of shop floor concerns related to production performance

• Provides hands on support in the phased introduction of process improvements required to meet Personnel and Material flow pattern objectives

• Generate change control and batch record documentation as necessary to support the introduction of new products and/or process improvements

• Investigates and executes risk-based solutions deemed necessary to address business operational and compliance challenges related to production processes

• Provides validation impact assessments for change controls including directing the identification and execution requirements deemed necessary to ensure quality and production robustness over time.

• Generates validation protocols, new production batch records, and standard operational procedures to assure accurate recording of critical process parameters in conformance to policies and procedures and in compliance with Good Documentation Practices

• Supports development and execution of Cleaning Validation and Computer Systems Validation programs

• Develops Knowledge Transfer and Training Plans for seamless transfer of new products and processes from the Clinical Developments and/or other site functions into routine commercial operations

• Supports the development and execution of QuVa Pharma policies, procedures, standards, and guidelines related to technical areas (Production, Validation, New Formulation Introduction, Root Cause Analysis, Process Trending, Risk Assessment, etc.)

• Engages with Engineering, Quality, and Operations to ensure equipment and manufacturing processes are appropriately designed to ensure on-time supply of products to meet customer requirements

• Ensures effective communication and collaboration between Commercial Operations, Quality Compliance partners and operational shop floor personnel

• Ensures all products and manufacturing processes are developed, validated, and transferred consistently

• Investigates process trends and complex deviations directing the execution of risk-based solutions deemed necessary to address business operational and compliance challenges

• Ensures transparency of technical program actions/deliverables

Our Most Successful Process Validation Engineers:

• Have strong problem-solving skills including training in the scientific method

• Demonstrate interpersonal communication skills

• Motivate cross functional teams to meet aggressive timelines

• Are proficient in technical writing and current computer usage (Word, Excel, PowerPoint)

• Have good working knowledge of regulatory guidance as it pertains to APIs and injectable drug products

Minimum Requirements for this Role:

• Bachelor's Degree in Chemistry, Biology, Pharmacy, Engineering, or an appropriate science related discipline required

• Minimum five years' experience in the manufacture, testing, and distribution of sterile Pharmaceutical/Biological products including experience in site-based manufacturing and/or quality operations roles

• Organizing and scheduling other people and their tasks; defining performance goals, measuring, and reporting performance against the goals

• Must be currently authorized to work in the United States on a full-time basis; QuVa is not able to sponsor applicants for work visas

Any of the Following Will Give You an Edge:

• Master's Degree

• Experience at multiple sites and across multiple functions

Benefits of Working at QuVa:

• Set, full-time, consistent work schedule

• Comprehensive health and wellness benefits including medical, dental and vision

• 401k retirement program with company match

• 17 paid days off plus 8 paid holidays per year

• National, industry-leading high growth company with future career advancement opportunities

About QuVa:

QuVa Pharma is a national, industry-leading, FDA registered 503B outsourcing services company that provides hospitals with essential medications in ready-to-administer injectable formats that are critical for effective patient care. We are leading the way with unmatched expertise in current Good Manufacturing Practices and sterile pharmaceutical manufacturing, and the highest quality and safety standards so hospitals can more confidently and reliably focus on patient care nationwide. As a leader in sterile compounding, we continue to invest in automation and integrated technologies to improve our production processes, safety, consistency, and product quality.

As part of our team, you'll experience being at the forefront of groundbreaking solutions, collaborating with brilliant minds, and making a tangible impact in healthcare delivery.

QuVa is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. QuVa's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with QuVa is "at will."